Method and apparatus for pre-forming a high tibial osteotomy

ABSTRACT

An osteotomy implant including a porous portion, a solid portion, and a hinge portion. The porous portion includes a first part and a second part that defines a clearance therebetween. A solid portion abuts the porous portion. A hinge portion of the solid portion is coupled to the first part and the second part. The hinge portion is configured to enable the implant to be changed from a first configuration to a second configuration.

FIELD

The present disclosure relates to a method and apparatus for pre-forminga high tibial osteotomy.

BACKGROUND

This section provides background information related to the presentdisclosure which is not necessarily prior art.

Various knee osteotomies are performed to adjust or change theorientation of the tibia to correct various abnormalities caused bybirth defects, trauma, or disease. High tibial osteotomies includeopen-wedge and closed-wedge osteotomies. Various implants designed tofill osteotomies exist. Some are modeled after a patient's specificanatomy, which increases the cost of the implant and complexity ofproduction. Therefore, a simplified and cost-effective osteotomy implantthat can be adjusted to fit a patient's anatomy would be desirable.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

The present teachings provide for an osteotomy implant including aporous portion, a solid portion, and a hinge portion. The porous portionincludes a first part and a second part that defines a clearancetherebetween. A solid portion abuts the porous portion. A hinge portionof the solid portion is coupled to the first part and the second part.The hinge portion is configured to enable the implant to be changed froma first configuration to a second configuration.

The present teachings also provide for an osteotomy implant including aporous metallic portion, a solid metallic portion, and a metallic hingeportion. The porous metallic portion includes a first part spaced apartfrom a second part. The solid metallic portion is integral with theporous metallic portion. The metallic hinge portion of the solidmetallic portion is one of aligned with or between the first part andthe second part. The hinge portion is configured to enable the implantto be changed from a first configuration to a second configuration.

The present teachings also provide for an osteotomy implant including agenerally “U” shaped loadbearing porous portion including a first partand a second part. The first part includes a first inner surface thatopposes a second inner surface of the second part. A solid portion iscoupled to both a first outer surface of the first part and a secondouter surface of the second part. The first outer surface is opposite tothe first inner surface and the second outer surface is opposite to thesecond inner surface. A flexible hinge portion is included with thesolid portion. The implant is bendable at the flexible hinge portion tocompress or expand the implant. The flexible hinge portion is configuredto enable the implant to be changed from a first configuration to asecond configuration.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1 illustrates an osteotomy implant according to the presentteachings for implantation in an osteotomy site of a tibia bone;

FIG. 2 is a perspective view of the implant of FIG. 1;

FIG. 3 is a perspective view of another osteotomy implant according tothe present teachings;

FIG. 4 is a perspective view of an additional osteotomy implant inaccordance with the present teachings;

FIG. 5 is a top view of yet another osteotomy implant according to thepresent teachings;

FIG. 6 is a top view of still another osteotomy implant according to thepresent teachings; and

FIG. 7 is a top view of an additional osteotomy implant according to thepresent teachings.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

Example embodiments will now be described more fully with reference tothe accompanying drawings.

With initial reference to FIGS. 1 and 2, an osteotomy implant accordingto the present teachings is generally illustrated at reference numeral10. As illustrated, the osteotomy implant 10 is for implantation atosteotomy site 12 of tibia 14. Femur 16 is also illustrated. The implant10 can also be implanted at an osteotomy site in the femur 16, such asduring a distal femoral osteotomy procedure.

The osteotomy implant 10 generally includes a porous portion 20 and asolid portion 22. The porous portion 20 generally includes a first part24 and a second part 26, which define a clearance or gap 28therebetween. Both the first part 24 and the second part 26 include aninner surface 30 and an outer surface 32, which is opposite to the innersurface 30. The first part 24 and the second part 26 are arranged suchthat the inner surface 30 of the first part 24 faces and is opposite tothe inner surface 30 of the second part 26. Each of the first part 24and the second part 26 further include an upper or superior surface 34,which is opposite to an under or inferior surface 36. The solid portion22 includes an inner surface 38, which is opposite to an outer surface40. The solid portion 22 extends across the outer surface 32 of each ofthe first part 24 and the second part 26 of the porous portion 20, andthus extends across the gap 28. The solid portion 22 includes a hinge42, such as a living hinge, opposite to the gap 28.

The implant 10 can be made of any suitable biocompatible materialsufficient to bear loads on the tibia 14 at the osteotomy site 12. Forexample, the implant 10 can be made out of a suitable metallic, such astitanium including commercially pure (CP) titanium or Grade 5 titaniumalloy (Ti6Al4V). An example of a suitable porous titanium construct thatthe implant can be made from is Regenerex® by Biomet of Warsaw, Ind. Anysuitable cobalt chrome based alloy may also be used. Both the porousportion 20 and the solid portion 22 can be made of the same material.The porous portion 20 can be made from any suitable implantable plastic,such as PEEK (polyether ether ketone) or PEKK (polyether ketone ketone).For example, the porous portion 20 can include ProOsteon® by Biomet ofWarsaw, Ind.

The implant 10 can be manufactured in any suitable manner. For example,the porous portion 20 and the solid portion 22 can be individuallymanufactured and then subsequently coupled or joined together using anysuitable coupling process. Other manufacturing processes that aresuitable include electron beam melting or any suitable additivemanufacturing process, such as a suitable additive metal fabricationtechnique. Using laser sintering, for example, the entire implant 10 canbe manufactured or printed together, such that the porous portion 20 andthe solid portion 22 are integrally formed and the implant 10 ismonolithic. The porous portion 20 can be formed in any suitable mannerthat will provide for pores into which bone growth may occur in order tofurther secure the implant 10 at the osteotomy site 12. The porousportion 20 is a generally “U” shaped, load-bearing portion able towithstand loads upon the tibia 14. Upon being inserted into theosteotomy site 12, the implant 10 will be retained within the osteotomysite 12 through friction between the tibia 14 and the porous portion 20.The solid portion 22 further increases the compression strength of theimplant 10 and prevents tissue from growing into the porous portion 20from outside of the osteotomy site 12. The porous portion 22 may includeribs 44, which are not porous to further increase the compressionstrength of the implant 10.

Implantation of the implant 10 at the osteotomy site 12 will now bedescribed. The implant 10 selected for implantation can be chosen from aplurality of implants 10 having a similar overall configuration, buthaving different general sizes to facilitate customization. For example,a plurality of implants 10 having different superior-inferior heightsand medial-lateral widths can be provided and selected based ondimensions of the osteotomy size 12. The width of the implant 10 isfirst compared to the width of the osteotomy site 12 in the anterior tothe posterior direction. The width of the implant 10 is generallyconsidered with respect to the distance between the first part 24 andthe second part 26 of the porous portion 20. If the width of the implant10 is wider than the width of the osteotomy site 12, then the implant 10can be compressed in order to decrease the width. If the width of theimplant 10 is narrower than the width of the osteotomy site 12, then theimplant 10 can be expanded in order to increase its width.

The implant 10 can be compressed (closed) or expanded (opened) eithermanually or using a suitable tool. The material of the solid portion 22is rigid enough to maintain structural integrity of the implant 10, butflexible enough to permit the implant 10 to be compressed in thismanner. As the first part 24 and the second part 26 are moved together,the gap 28 therebetween will become smaller. As the first part 24 andthe second part 26 are moved apart, the gap 28 therebetween will becomelarger. Specifically, implant 10 pivots generally at the hinge 42, whichcan be configured in any suitable manner to facilitate bending of thesolid portion 22, such as with a thinned portion, a notched portion, orany weakened portion. The first part 24 and the second part 26 can becompressed or expanded to any suitable position, such as between a firstconfiguration and a second configuration, thus providing the implant 10with a near infinite number of medial-lateral widths. The rigidity ofthe solid portion 22 will maintain the implant 10 in the compressed orexpanded position to provide the implant 10 with a desiredmedial-lateral width to fit the osteotomy site 12. As the first part 24and the second part 26 are moved, the solid portion 22 bends at thehinge 42. The implant 10 is retained within the osteotomy site 12 due tofriction between the portion of the tibia 14 at the osteotomy site 12and the porous portion 20. The implant 10 will be further retainedwithin the osteotomy site 12 by bone ingrowth into the porous portion20. The implant 10 can also be retained within the osteotomy site 12with any suitable retention device or feature, such as a suitablelocking plate.

With additional reference to FIG. 3, another osteotomy implant accordingto the present teachings is illustrated at reference numeral 50. Theimplant 50 is similar to the implant 10, and thus similar features aredesignated with similar reference numbers, and the description of thesesimilar features set forth above in the description of the implant 10also applies to the implant 50. The implant 50 can also be formed of thesame material as the implant 10, and manufactured in the same manner.Unlike the implant 10, the solid portion 22 of the implant 50 is at theinner surface 30 of the porous portion 20. Providing the solid portion22 at the inner surface 30 will typically increase the overallstructural integrity of the implant 50.

Another osteotomy implant according to the present teachings isillustrated in FIG. 4 at reference numeral 60. The implant 60 is similarto the implant 10, and thus similar features are designated with similarreference numbers, and the description of these similar features setforth above in the description of the implant 10 also applies to theimplant 60. The implant 60 can also be formed of the same material asthe implant 10, and manufactured in the same manner.

The porous portion 20 of the implant 60 is divided into a plurality ofporous parts 20A through 20F. Each of the porous parts 20A-20F issurrounded by the solid portion 22. Between adjacent ones of the porousparts 20A-20F, the solid portion 22 includes the hinge 42, and thus aplurality of hinges 42A-42E are provided to link together the pluralityof porous parts 20A-20F. Any suitable number of porous portions 20 canbe included with the implant 60 depending on the size of the osteotomysite 12. To optimize fit between the implant 60 and the osteotomy site12, the implant 60 can be flexed or compressed either inward or outwardat any of the hinges 42A-42E, allowing the implant 60 to be flexed orcompressed to nearly an infinite number of positions. The porousportions 20 define therebetween a plurality of clearances or gaps 28that allow the implant 60 to be flexed inward and outward at the hinges42. The width of the clearances or gaps 28 can be set to limit theamount of flex between the porous portions 20. The porous portions20A-20F are exposed at the upper surfaces 34 and the under surfaces 36thereof in order to permit bone growth therein, which further securesthe implant 60 at the osteotomy site 12. The thickness of the hinge 42can be adjusted to control the flexibility of the hinge 42.

Another osteotomy implant according to the present teachings isillustrated in FIG. 5 at reference numeral 70. The implant 70 is similarto the implant 10, for example, and thus like features are illustratedand described using similar reference numbers. The implant 70 can alsobe manufactured in the same way described above with respect to theimplant 10. Unlike the implant 10, the implant 70 includes a hinge 42with a ball 42F and a socket 42G. The ball 42A extends from the firstsolid portion 22A of the first part 24 of the porous portion 20. Thesocket 42G is defined within second solid portion 22B of the second part26 of the porous portion 20. The clearance or gap 28 is defined betweenthe first part 24 and the second part 26 of the porous portion 20. Theball and socket hinge 42F/42G can be formed in any suitable manner, suchas using electron beam melting or direct metal laser sintering, whichallows the ball and socket hinge 42F/42G to be “printed” together withthe rest of the implant 70, such as by direct metal laser sintering orany other additive metal fabrication technique. Other suitable hingesinclude, for example, a barrel hinge and a butt hinge.

The ball and socket hinge 42F/42G facilitates movement of the first part24 and the second part 26 of the porous portion 20 together or apart inorder to decrease or increase the medial-lateral width of the implant tocorrespond to the implant site 12. When set at the desiredmedial-lateral width, the ball and socket hinge 42F/42G will retain theimplant 70 at the set width in any suitable manner, such as by frictionbetween the ball 42F and the socket 42G, or with any suitable lockingdevice. Although the implant 70 is not illustrated with the first solidportion 22A extending entirely across the outer surface 32 of each ofthe first part 24 of the porous portion 20, the first solid portion 22Acan be lengthened to extend entirely across the outer surface 32 of thefirst part 24. Similarly, the second solid portion 22B can be lengthenedso as to extend across the entire outer surface 32 of the second part 26of the porous portion 20. The ball 42F and the socket 42G can beprovided in place of the hinge 42 of any one of the implants 10, 50, or60, as well as the implants 80 and 90 described herein.

Yet another osteotomy implant according to the present teachings isillustrated in FIG. 6 at reference numeral 80. The implant 80 is similarto the implant 10 of FIG. 2, and thus like reference numerals are usedto illustrate the similar features. The description of these likefeatures set forth in the description of the implant 10 also applies tothe implant 80. The implant 80 can be manufactured in the same mannerset forth above with respect to the implant 10. Unlike the implant 10,the implant 80 includes an adjustment member, such as a fastener 82,extending through an aperture 84 defined in the solid portion 22. Thefastener 82 also extends through portions of the porous portion 20 fromthe second part 26 to the first part 24, and thus spans the clearance orgap 28 therebetween. The fastener 82 can be threaded directly into thefirst part 24, or the first part 24 can include a threaded receptacle 86to cooperate with the fastener 82. The fastener 82 facilitatescompression and expansion of the first part 24 and the second part 26 ofthe porous portion 20. Specifically, as the fastener 82 is rotated in afirst direction, such as with a suitable device, the fastener 82 willdraw the first and second parts 24 and 26 together. As the fastener 82is rotated in a second direction, the fastener 82 will push the firstand second parts 24 and 26 apart. This will cause the solid portion 22to generally bend about the hinge 42. The fastener 82 can be providedwith any one of the implants 10, 50, 60, or 70.

FIG. 7 illustrates another osteotomy implant according to the presentteachings at reference numeral 90. The implant 90 is similar to theimplant 10, and thus features in common with the implant 10 areillustrated using common reference numbers. The solid portion 22 definesan aperture 92 proximate to hinge 42 of the implant 90. Seated withinand extending through the aperture 92 is an adjustment member, such as afastener 94. The fastener 94 is threaded into a nut 96 seated betweenthe first part 24 and the second part 26 of the porous portion 20.Specifically, the nut 96 abuts the inner surface 30 of each of the firstand second parts 24 and 26. As the screw is rotated with a suitabledevice, the screw will further cooperate with threads of the nut 96 todraw the nut 96 toward the solid portion 22, thereby causing the nut 96to apply pressure to each of the inner surfaces 30 of the first andsecond parts 24 and 26 to force the first part 24 and the second part 26apart, and thus increase the width of the implant 90 to fit a widerosteotomy site 12 from a first dimension to a second greater dimension.

The foregoing description of the embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

What is claimed is:
 1. An osteotomy implant comprising: a porous portionincluding a first part with a first sidewall and a second part with asecond sidewall, a clearance is defined between the first sidewall andthe second sidewall; a solid portion abutting the porous portion, thefirst and the second sidewalls extending from the solid portion todefine the clearance; and a hinge portion of the solid portion coupledto the first part and the second part; wherein the hinge portion isconfigured to enable the implant to be changed from a firstconfiguration to a second configuration the implant further comprisingan adjustment member, wherein the adjustment member extends from thefirst part to the second part across the clearance defined between thefirst part and the second part; wherein rotation of the adjustmentmember in a first direction draws the first part and the second parttogether, and rotation of the adjustment member in a second directionpushes the first part and the second part apart.
 2. The osteotomyimplant of claim 1, wherein the porous portion includes at least one ofa metallic, PEEK, or PEKK.
 3. The osteotomy implant of claim 1, whereinthe porous portion includes a porous upper surface and a porous lowersurface configured to receive bone ingrowth.
 4. The osteotomy implant ofclaim 3, wherein the solid portion is coupled to an outer surface of theporous portion, the osteotomy implant formed by additive manufacturing.5. The osteotomy implant of claim 4, wherein the solid portion isintegral with the outer surface of the porous portion and is loadbearing.
 6. The osteotomy implant of claim 1, further comprising aplurality of solid, spaced apart, load bearing ribs with the porousportion therebetween.
 7. The osteotomy implant of claim 1, wherein thesolid portion includes at least one of a metallic, PEEK, or PEKK.
 8. Theosteotomy implant of claim 1, wherein the implant is monolithic.
 9. Anosteotomy implant comprising: a generally “U” shaped loadbearing porousportion including a first part and a second part, the first partincludes a first inner surface that opposes a second inner surface ofthe second part, a clearance is defined between the first inner surfaceand the second inner surface; a solid portion coupled to both a firstouter surface of the first part and a second outer surface of the secondpart, the first outer surface is opposite to the first inner surface andthe second outer surface is opposite to the second inner surface; and aflexible hinge portion of the solid portion; wherein the implant isbendable at the flexible hinge portion to compress or expand theimplant; wherein the flexible hinge portion is configured to enable theimplant to be changed from a first configuration to a secondconfiguration upon actuation of an adjustment member at the clearance,the first and the second parts are closer together in the secondconfiguration than in the first configuration.
 10. The osteotomy implantof claim 9, wherein both the porous portion and the solid portioninclude at least one of a metallic, PEEK, or PEKK.
 11. The osteotomyimplant of claim 9, wherein the adjustment member includes a fastenerextending from the first part to the second part across the clearancedefined between the first part and the second part, rotation of thefastener in a first direction draws the first part and the second parttogether, rotation of the fastener in a second direction pushes thefirst part and the second part apart.
 12. The osteotomy implant of claim9, wherein the adjustment member is arranged in the clearance andextends from the first part to the second part, actuation of theadjustment member in a first direction draws the first part and thesecond part together, actuation of the adjustment member in a seconddirection opposite to the first direction moves the first part and thesecond part apart.
 13. The osteotomy implant of claim 9, wherein thefirst and the second inner surfaces extend directly from the solidportion.
 14. The osteotomy implant of claim 13, wherein the first andthe second inner surfaces extend linearly.
 15. The osteotomy implant ofclaim 13, wherein the first and the second inner surfaces define theclearance as wedge-shaped.
 16. An osteotomy implant comprising: a porousportion including a first part and a second part that defines aclearance therebetween; a solid portion abutting the porous portion; anda hinge portion of the solid portion coupled to the first part and thesecond part, the hinge portion is configured to enable the implant to bechanged from a first configuration to a second configuration; and anadjustment member configured to change the implant from the firstconfiguration to the second configuration; wherein the adjustment memberincludes a fastener extending from the first part to the second partacross the clearance defined between the first part and the second part,rotation of the fastener in a first direction draws the first part andthe second part together, rotation of the fastener in a second directionpushes the first part and the second part apart.